Pegasus Laboratories, Inc. ยท 1 day ago
Validations Engineer
Pensacola, FL
Full-time
Onsite
Mid, Senior Level
2+ years expPBI-Gordon Companies, along with its subsidiaries, prioritizes people, pets, and the places they go. The Validation Engineer II is responsible for process and product validation from equipment design to FDA approval, managing projects to maximize efficiency and safety while applying lean manufacturing principles.
BiotechnologyClinical TrialsHealth CareManufacturing
Responsibilities
Oversee manufacturing equipment and facility commissioning projects including design, selection, and qualification
Develop protocols and write reports; to appropriately design the protocols, must be able to understand the purpose and objective of the study
Able to write and execute IQ, OQ and PQ protocols against project timelines
Has effective organization and time management skills
Multi-tasks well, delegates appropriately and considers others when planning
Develops effective plans, anticipates problems and looks for contingencies
Supports project technical development (Manufacturing Controls), from formulations to approval and launch as it applies to project design
Works with Formulators during laboratory batches to understand the process
Is able to navigate complex projects and view problems as opportunities
Shows confidence in ambiguous and stressful situations
Solicits and welcomes feedback from others
Able to design and perform the execution of sampling and sample preparation in support of cleaning, process, and packaging validation protocols
Must be able to analyze and review raw data and interpret results
Write final reports in accordance with industry and company standards
Able to build strong relationships and relate well with the different departments to reach common corporate goals
Managing and monitors assigned product validation projects including cleaning and manufacturing processes
Utilize a risk-based approach to establish and maintain the validation program specific to product
Responsible for project planning and justification; works with various departments to develop project budgets and timelines to manage the project effectively
Identifies and translates priorities into clear, actionable goals and tactics
Accountable for training manufacturing and production personnel on new equipment, cleaning procedures, and manufacturing processes
Build strong relationships and relate well with others to drive results to meet personal, company and corporate goals
Shows personal commitment and takes actions to continuously improve
Accepts opportunities that broaden capabilities
Applies what has been learned to improve future experiences for self, others, and company
Other duties as assigned
Qualification
Required
BS with 2-5 years of relevant experience or MS or PhD in Chemical or Mechanical Engineering or a related discipline
Must have 2+ years Pharmaceutical Process Development and Validations experience
Experience with Process Validations, Cleaning Validations, Scale-up, and equipment qualifications
Experience with performing IQ, OQ and PQ functions for equipment used on different products (tablets, solutions, or topicals)
Strong Technical writing and documentation skills are necessary (cGMP, protocols, reports, OOS investigations, and laboratory notebook documentation)
Must be able to climb into confined spaces and able to lift 50 lbs. (ie. Swabbing tanks, utilities mezzanines) and stand for extended periods of time
Preferred
5+ years Pharmaceutical Process Development and Validations experience
Statistical process performance and Project Management
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance with Accidental Death & Dismemberment (AD&D)
Short- and Long-term Disability
Employee Assistance Program (EAP)
Flexible Spending Account (FSA)
Pet Insurance
Paid Holidays & Paid Time Off (PTO)
Employee Stock Ownership Plan (ESOP)
401(k) Retirement Savings Plan
Fitness Reimbursement
William Everett & Mary Ellen Mealman Scholarship Fund
Tuition Reimbursement
Parental Leave
Company
Pegasus Laboratories, Inc.
About Us Pegasus Laboratories was founded in 1986 and acquired by PBI-Gordon Corporation in 1999.
51-200 employees
H1B Sponsorship
Pegasus Laboratories, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Growth StageLeadership Team
Lisa Glazier, MBA, SPHR, SHRM-CP
Human Resources Business Partner
Recent News
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